OBR Daily Commentary

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From Twitter To Treatment Guidelines, Industry Influence Permeates Medicine

(NPR/ProPublica) Jan 17, 2017 - The long arm of the pharmaceutical industry continues to pervade practically every area of medicine, reaching those who write guidelines that shape doctors' practices, patient advocacy organizations, letter writers to the Centers for Disease Control and Prevention and even oncologists on Twitter, according to a series of papers on money and influence published Tuesday in JAMA Internal Medicine.

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William McGivney, PhD (Posted: January 25, 2017)

quotesSupport received by organizations from various stakeholders for educational programs and other activities at provider or patient not-for-profits is a valid issue, especially when such an organization(s) might have considerable influence over practice norms and coverage policy. However, it is always interesting to note the amblyopic view of researchers and the media who focus their efforts only on one side and the easy target. When I was CEO of a major provider organization, I decided to address my limited curiosity by having each grant request (for mainly educational programs) that was sent to a pharma company be also sent (the same grant request) to major payers. One year at our Annual Conference, I was listening to a Panel discussion addressing this issue and was compelled to make a public comment. The organization had sent over thirty requests for support for educational programs to major payers and we had a uniform answer to all such requests. That answer was “NO”. I suggest that researchers make sure that they understand the entire system and not close the one eye that should hold a field of vision that includes other stakeholders (e.g., payers) in their quest for veracity. quotes

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CMS Announces Changes in MACRA Implementation Timeline

(ASH) Sept 12, 2016 - The Centers for Medicare and Medicaid Services (CMS) announced major changes to the implementation of the Medicare Access and CHIP Reauthorization (MACRA). Acting Administrator Andy Slavitt outlined how physicians can choose to participate at their own pace in the new quality program and avoid any penalties in the first year of implementation.

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William McGivney, PhD (Posted: September 16, 2016)

quotesThe announced changes in the timeline for implementation of payment aspects and programs authorized under MACRA is indeed a prudent move. There are many issues at play here but the most important has been the drive on the part of CMS to be able to say that we have moved “X” percent of providers away from Fee for Service Reimbursement or in the case of Oncology, Fee For Service/Buy and Bill (FFS/B&B). Since MACRA passed, there has been a paroxysm of activity with multiple and blended payment methods being put forth by CMS for Oncology. Indeed, incentive-based payment (largely based on some quality measures), bundled payment, Value-based payment and a combination of methods under the Oncology Care Model (OCM) all have been advanced with short turnaround timelines for implementation (e.g., participation) by providers and provider institutions. This has left many providers asking the "age-old" (or at least "old")question: “Is this any way to run a railroad” or for them an “Oncology Practice”. Based upon this prudent CMS delay, it might be wise for CMS to continue on this measured path and clearly state that for CMS the move to incentive-based payment and the continuation of the OCM demonstration are now the priority foci for payment method change for the foreseeable future. Surely, the somewhat easier pivot to incentive based payment under Medicare will allow those who need to, to state that CMS is indeed moving the needle and moving physician oncologists away from FFS/B&B without CMS continuing the almost frenetic disruptions to core businesses (e.g., centers, practice groups) trying to deliver needed care to cancer patients. quotes

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Off-Label Cancer Drug Use -- Compendia in Need of Overhaul

(Medscape Medical News) Sept 6, 2016 - Cancer drugs are often used off label for indications that are not approved – but the system that covers the reimbursement for such use is inconsistent and needs to be overhauled, oncologists argue in an opinion piece published online August 25 in JAMA.

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William McGivney, PhD (Posted: September 12, 2016)

quotesThe recent Viewpoint in JAMA entitled “Time to Reassess Compendia for Off-Label Coverage in Oncology” represents the periodic, punctilious presentation of the deficiencies in the Compendium products. This time, the authors conclude with the bemusing recommendation that “this function would be most appropriately performed under the direct oversight of the FDA….”. As the founder of the NCCN Drugs/Biologics Compendium, the most authoritative of the now 5 Medicare recognized compendia, I always encourage those developers of a couple of pages of such “critical” insights to: rather leave their keyboards, address their own criticisms and actually build, operate and improve on the processes and products that are currently available. Indeed, for the NCCN, the NCCN Drugs/Biologics Compendium is derived directly from the recommendations of the NCCN Guidelines as developed by over 1,000 of the world’s leading clinical experts who share their expertise and experience (on a volunteer basis) across the 46 tumor specific, supportive care specific, and prevention specified panels. The recommendations are provided in a timely fashion. The ongoing evaluative process allows for continuous updating including the rare event of deleting a previous recommendation. In 2015, the Non Small Lung Cancer Panel published 7 versions. The authors of the JAMA paper could and can readily access (free of charge) the statements of potential Conflicts of Interest online at the NCCN for all 1,000 Panel members and NCCN staff (pretty good transparency). I wonder how many true experts could be found who have “no financial relationships with the pharmaceutical industry”. Again, the challenge is not to write about the issue yet again but to compete in the marketplace. Experts out there are free to design, develop, implement and operate their processes. Then the Marketplace Stakeholders will decide. As such, I wonder why the NCCN Compendium now continues to be the most influential, used and cited of all available compendia, including by payers. Also, the NCCN Guidelines are available free of charge to all and the NCCN Compendium is available for under $600. I hope that that addresses the authors’ claim that this limits “the possibility of public scrutiny or availability to organizations that do not subscribe”. A new marketing slogan is born: “To scrutinize and criticize, please subscribe!” Clearly, ongoing evaluation of processes is important. However, repetitive criticisms with no real positive plan and action to address deficiencies becomes a vacuous exercise. The development of a Compendium process and product takes years, takes thousands of expert clinician volunteers, and takes a receptive marketplace (e.g., payers) that recognizes the authority of that product’s pronouncements. As one wise person once said: “The Perfect is the Enemy of the Good” quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...